Hatch, Casey Put Forward Bill to Encourage Antibiotic Innovation

Bipartisan Legislation Aims to Address the Critical Shortage of Research and Development of Advanced Antibiotics

WASHINGTON – Senate Finance Committee Chairman Orrin Hatch (R-Utah) and committee member Senator Bob Casey (D-Pa.) today introduced S. 3787 the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act of 2018, bipartisan legislation to address the lack of research and development for advanced antibiotics.

These drugs are needed to combat the rising rates of antibiotic resistant pathogens, such as carbapenem-resistant Enterobacteriaceae (CRE) infections which are increasing among patients receiving treatments in medical facilities. If current trends continue, one study estimates that 300 million people worldwide could die prematurely in the next 35 years as a result of antimicrobial resistant infections.

“America’s next health emergency is already here,” Hatch said. “Each year, approximately 23,000 Americans contract antibiotic-resistant infections and pass away. As more of these bacterial infections emerge, drugmakers must develop new or improved antibiotic therapies to treat high-priority infections. However, making these drugs is risky and expensive. Along with a lack of research, significant barriers have slowed creating new therapies considerably, with only 12 new brand-name antibiotics developed in the last 18 years. DISARM is one solution to this problem and serves to alert our colleagues about the desperate need for debate and fiscally responsible legislative action. Senator Casey and I want to encourage the development of novel drug and biological products that treat these serious and life-threatening infections. Working together with researchers, physicians, hospitals and other healthcare providers, we will find solutions that ensure good stewardship and help overcome economic obstacles to innovate in this area.”

“Antibiotic resistance is one of the most significant public health threats facing the nation,” Casey said. “Every threat we face – from common diseases like influenza or cancer, to natural disasters, to emerging infectious diseases or chemical, biological, radiological and nuclear threats – becomes more dangerous without antibiotics to treat the opportunistic infections that follow. We must continue to explore new ideas to strengthen the research and development pipeline and encourage new antibiotic development. This proposal is intended to facilitate future discussion about policies that the federal government and private health care payers should consider to stabilize the market for antibiotics and ensure that the next antibiotic is always available when needed. I would like to thank Senator Hatch for his leadership on this issue, and I look forward to continuing this important work.”

Bill text of S. 3787 can be found here.

More on the DISARM Act:

To encourage development and use of next generation/advanced antibiotics, DISARM would allow Medicare to offer an add-on payment to inpatient hospitals that use a qualifying DISARM antibiotic to treat a serious or life-threatening infection.
Qualifying hospitals must participate in a specified Centers for Disease Control (CDC) antibiotic stewardship program in order to be eligible for a DISARM add-on payment.
The legislation aims to strengthen the antibiotic research and development pipeline and offer more effective treatment for the more than 2 million Americans who are infected with bacteria that are resistant to antibiotics each year.

Background: Chairman Hatch was the lead co-author of the Generating Antibiotic Incentives Now (GAIN) Act in 2012, which gave companies enhanced tools that encouraged the development of new antibiotics. Under this program, new drug applications that are designated as qualified infectious disease products (QIDPs) can receive fast track designation, priority review designation and a possible five-year extension of any exclusivity that the application qualifies for upon approval.

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